Trial Outcomes & Findings for A Trial In Patients With Advanced Cancer And Leukemia (NCT NCT00878189)

Last Updated: 2019-11-12

Results Overview

Any DLT event attributable to PF-03084014 during Cycle 1: non-hematologic toxicities \>= Grade 3 despite optimal care; treatment delay \>=7 days or unable to deliver at least 80% of planned dose due to treatment-related toxicities; Grade 4 neutropenia \>7 days; febrile neutropenia; neutropenic infection; Grade \>=3 thrombocytopenia with bleeding

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

72 participants

Primary outcome timeframe

Baseline to the end of Cycle 1 (Week 4)

Results posted on

2019-11-12

Participant Flow

This study originally planned to give PF-03084014 in combination with dexamethasone in participants with solid tumors and with T-cell acute lymphoblastic leukemia and lymphoblastic lymphoma, including a drug-drug-interaction test of PF-03084014 and dexamethasone in solid tumor participants. But these parts were removed per protocol amendments.

Participant milestones

Participant milestones
Measure	PF-03084014 20 mg BID in Solid Tumor Participants PF-03084014 20 mg was administered orally twice daily (BID), beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of pharmacokinetic (PK) assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 40 mg BID in Solid Tumor Participants PF-03084014 40 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 80 mg BID in Solid Tumor Participants PF-03084014 80 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 100 mg BID in Solid Tumor Participants PF-03084014 100 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 130 mg BID in Solid Tumor Participants PF-03084014 130 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Overall Study STARTED	3	3	4	8	4	23	16	3	8
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	3	3	4	8	4	23	16	3	8

Reasons for withdrawal

Reasons for withdrawal
Measure	PF-03084014 20 mg BID in Solid Tumor Participants PF-03084014 20 mg was administered orally twice daily (BID), beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of pharmacokinetic (PK) assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 40 mg BID in Solid Tumor Participants PF-03084014 40 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 80 mg BID in Solid Tumor Participants PF-03084014 80 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 100 mg BID in Solid Tumor Participants PF-03084014 100 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 130 mg BID in Solid Tumor Participants PF-03084014 130 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Overall Study Death	0	1	0	1	0	0	0	0	1
Overall Study Participant Refused to Follow-up	0	0	0	0	0	4	0	0	0
Overall Study Other	3	2	4	7	4	18	15	3	4
Overall Study Lost to Follow-up	0	0	0	0	0	1	1	0	0
Overall Study Objection Progression or Relapse	0	0	0	0	0	0	0	0	3

Baseline Characteristics

A Trial In Patients With Advanced Cancer And Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PF-03084014 in Solid Tumor Participants n=64 Participants PF-03084014 was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 in T-ALL/LBL Participants n=8 Participants PF-03084014 150 mg was administered orally BID to participants with T-ALL/LBL as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	Total n=72 Participants Total of all reporting groups
Age, Continuous	55.6 years STANDARD_DEVIATION 14.7 • n=5 Participants	30.8 years STANDARD_DEVIATION 9 • n=7 Participants	52.9 years STANDARD_DEVIATION 16.1 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	2 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	6 Participants n=7 Participants	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to the end of Cycle 1 (Week 4)

Population: Solid tumor participants enrolled for dose-escalation who started treatment and who did not have first cycle major treatment deviations (including less than 80% of the planned dose of PF-03084014 in Cycle 1 for reasons other than treatment-related toxicities) were evaluable for DLTs.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=6 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=6 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=6 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Number of Solid Tumor Participants With First-Cycle Dose-Limiting Toxicity (DLT)	0 participants	0 participants	0 participants	1 participants	0 participants	1 participants	1 participants	2 participants	—

PRIMARY outcome

Timeframe: Baseline to the end of Cycle 1 (Week 4)

Population: T-ALL/LBL participants enrolled for dose-escalation who started treatment and who did not have first cycle major treatment deviations (including less than 80% of the planned dose of PF-03084014 in Cycle 1 for reasons other than treatment-related toxicities) were evaluable for DLTs.

Any DLT attributable to PF-03084014 at 1st Cycle: non-hematologic toxicities \>= Grade 3 despite optimal care; treatment delay \>=7 days; unable to deliver at least 80% of planned dose; absolute neutrophil count (ANC) \<1000/microliter (uL), or platelet count \<30,000/uL, or hemoglobin \<8 gram/deciliter (g/dL) in a bone marrow with \<5% blasts and no evidence of leukemia or abnormal dysplasia for \>42 days

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=5 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Number of T-ALL/LBL Participants With First-Cycle DLT	1 participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to end of study (maximum of 84 months)

Population: All participants who received at least 1 dose of study medication.

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of casual relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), and resulted in congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=8 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=23 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=16 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants n=8 Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causality) No. of Participants With Dose Reduction Due to AEs	0 participants	0 participants	0 participants	0 participants	1 participants	4 participants	3 participants	1 participants	1 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causality) No. of Participants With AEs	3 participants	3 participants	4 participants	7 participants	4 participants	23 participants	16 participants	3 participants	8 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causality) No. of Participants With SAEs	1 participants	1 participants	2 participants	4 participants	2 participants	8 participants	7 participants	2 participants	4 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causality) No. of Participants Discontinued PF-03084014	0 participants	1 participants	0 participants	2 participants	1 participants	1 participants	4 participants	2 participants	3 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causality) No. of Participants Temp. Discontinued Treatment	1 participants	1 participants	2 participants	1 participants	1 participants	9 participants	5 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: Baseline up to end of study (maximum of 84 months)

Population: All participants who received at least 1 dose of study medication.

An AE was any untoward medical occurrence in a participant who received study drug. Treatment-related events were those assessed by the investigator as related to study medication. An SAE was any untoward medical occurrence at any dose that: resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), and resulted in congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=8 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=23 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=16 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants n=8 Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Number of Participants With TEAEs (Treatment-Related) No. of Participants With AEs	2 participants	1 participants	2 participants	6 participants	4 participants	20 participants	16 participants	3 participants	5 participants
Number of Participants With TEAEs (Treatment-Related) No. of Participants With SAEs	0 participants	0 participants	0 participants	1 participants	1 participants	0 participants	1 participants	0 participants	1 participants
Number of Participants With TEAEs (Treatment-Related) No. of Participants Discontinued PF-03084014	0 participants	0 participants	0 participants	1 participants	0 participants	1 participants	1 participants	1 participants	0 participants
Number of Participants With TEAEs (Treatment-Related) No. of Participants Temp. Discontinued Treatment	0 participants	0 participants	0 participants	0 participants	1 participants	7 participants	4 participants	1 participants	0 participants
Number of Participants With TEAEs (Treatment-Related) No.of Participants With Dose Reduction Due to AEs	0 participants	0 participants	0 participants	0 participants	1 participants	4 participants	3 participants	1 participants	1 participants

SECONDARY outcome

Timeframe: Baseline up to end of study (maximum of 84 months)

Population: All participants who received at least 1 dose of study medication.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. CTCAE version 3.0 was used for AE grading: Grade 1 mild AE; Grade 2 moderate AE; Grade 3 severe AE; Grade 4 life-threatening or disabling AE; Grade 5 death related to AE.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=8 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=23 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=16 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants n=8 Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causality) by Severity (by Maximum Common Terminology Criteria for Adverse Events [CTCAE] Grade) Any AEs, Grade 1	0 participants	0 participants	1 participants	1 participants	0 participants	1 participants	1 participants	0 participants	1 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causality) by Severity (by Maximum Common Terminology Criteria for Adverse Events [CTCAE] Grade) Any AEs, Grade 2	2 participants	1 participants	0 participants	1 participants	2 participants	8 participants	3 participants	0 participants	1 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causality) by Severity (by Maximum Common Terminology Criteria for Adverse Events [CTCAE] Grade) Any AEs, Grade 3	1 participants	1 participants	2 participants	2 participants	2 participants	12 participants	9 participants	2 participants	4 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causality) by Severity (by Maximum Common Terminology Criteria for Adverse Events [CTCAE] Grade) Any AEs, Grade 4	0 participants	0 participants	1 participants	2 participants	0 participants	2 participants	1 participants	1 participants	1 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causality) by Severity (by Maximum Common Terminology Criteria for Adverse Events [CTCAE] Grade) Any AEs, Grade 5	0 participants	1 participants	0 participants	1 participants	0 participants	0 participants	2 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: Baseline up to end of study (maximum of 84 months)

Population: All participants who received at least 1 dose of study medication.

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-related events were those assessed by the investigator as related to study medication. CTCAE version 3.0 was used for AE grading: Grade 1 mild AE; Grade 2 moderate AE; Grade 3 severe AE; Grade 4 life-threatening or disabling AE; Grade 5 death related to AE.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=8 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=23 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=16 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants n=8 Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Number of Participants With TEAEs (Treatment-Related) by Severity (by Maximum CTCAE Grade) Any AEs, Grade 1	1 participants	0 participants	1 participants	1 participants	1 participants	6 participants	2 participants	0 participants	3 participants
Number of Participants With TEAEs (Treatment-Related) by Severity (by Maximum CTCAE Grade) Any AEs, Grade 2	1 participants	1 participants	0 participants	3 participants	2 participants	6 participants	4 participants	1 participants	0 participants
Number of Participants With TEAEs (Treatment-Related) by Severity (by Maximum CTCAE Grade) Any AEs, Grade 3	0 participants	0 participants	1 participants	1 participants	1 participants	8 participants	10 participants	2 participants	1 participants
Number of Participants With TEAEs (Treatment-Related) by Severity (by Maximum CTCAE Grade) Any AEs, Grade 4	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With TEAEs (Treatment-Related) by Severity (by Maximum CTCAE Grade) Any AEs, Grade 5	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With TEAEs (Treatment-Related) by Severity (by Maximum CTCAE Grade) Missing or Unknown	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: Baseline up to end of study (maximum of 84 months)

Population: All participants who received at least 1 dose of study medication.

Criteria for potentially important changes in ECG were defined as: maximum (max.) post-dose (post-baseline) time from electrocardiogram Q wave to the corresponding to electrical systole (QT interval) corrected for Fridericia's factor (QTcF), or QT interval corrected for Bazett's factor (QTcB): \<450, 450 -\<480, 480-\<500, and \>=500 msec. Maximum increase (inc.) from baseline in QTcF or QTcB: change (chg) \<30, 30\>=chg\<60, and chg \>=60 msec.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=8 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=23 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=16 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants n=8 Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Number of Participants With Potentially Clinical Significant Categorical Changes From Baseline in Electrocardiogram (ECG) Findings in QTc Interval Max. QTcF interval 450-<480 msec	0 participants	0 participants	1 participants	0 participants	1 participants	9 participants	2 participants	0 participants	0 participants
Number of Participants With Potentially Clinical Significant Categorical Changes From Baseline in Electrocardiogram (ECG) Findings in QTc Interval Max. QTcF interval 480-<500 msec	0 participants	0 participants	0 participants	1 participants	0 participants	1 participants	0 participants	0 participants	0 participants
Number of Participants With Potentially Clinical Significant Categorical Changes From Baseline in Electrocardiogram (ECG) Findings in QTc Interval Max. QTcF interval >=500 msec	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants	2 participants	0 participants	0 participants
Number of Participants With Potentially Clinical Significant Categorical Changes From Baseline in Electrocardiogram (ECG) Findings in QTc Interval Max. QTcB interval inc. from baseline chg<30 msec	1 participants	2 participants	1 participants	7 participants	3 participants	21 participants	7 participants	3 participants	7 participants
Number of Participants With Potentially Clinical Significant Categorical Changes From Baseline in Electrocardiogram (ECG) Findings in QTc Interval Max. QTcF interval inc. from baseline chg>=60 msec	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants	2 participants	0 participants	0 participants
Number of Participants With Potentially Clinical Significant Categorical Changes From Baseline in Electrocardiogram (ECG) Findings in QTc Interval Max. QTcB interval inc. from baseline chg>=60 msec	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants	2 participants	0 participants	0 participants
Number of Participants With Potentially Clinical Significant Categorical Changes From Baseline in Electrocardiogram (ECG) Findings in QTc Interval Max. QTcF interval inc. from baseline chg<30 msec	3 participants	2 participants	1 participants	7 participants	3 participants	22 participants	12 participants	3 participants	8 participants
Number of Participants With Potentially Clinical Significant Categorical Changes From Baseline in Electrocardiogram (ECG) Findings in QTc Interval Max. QTcF interval inc. from baseline 30=<chg<60	0 participants	1 participants	2 participants	1 participants	1 participants	1 participants	2 participants	0 participants	0 participants
Number of Participants With Potentially Clinical Significant Categorical Changes From Baseline in Electrocardiogram (ECG) Findings in QTc Interval Max. QTcB interval >=500 msec	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants	2 participants	0 participants	8 participants
Number of Participants With Potentially Clinical Significant Categorical Changes From Baseline in Electrocardiogram (ECG) Findings in QTc Interval Max. QTcB interval inc. from baseline 30=<chg<60	2 participants	1 participants	2 participants	1 participants	1 participants	2 participants	7 participants	0 participants	1 participants
Number of Participants With Potentially Clinical Significant Categorical Changes From Baseline in Electrocardiogram (ECG) Findings in QTc Interval Max. QTcB interval 480-<500 msec	0 participants	0 participants	0 participants	1 participants	0 participants	4 participants	0 participants	0 participants	8 participants
Number of Participants With Potentially Clinical Significant Categorical Changes From Baseline in Electrocardiogram (ECG) Findings in QTc Interval Max. QTcF interval <450 msec	3 participants	3 participants	2 participants	7 participants	3 participants	13 participants	12 participants	3 participants	8 participants
Number of Participants With Potentially Clinical Significant Categorical Changes From Baseline in Electrocardiogram (ECG) Findings in QTc Interval Max. QTcB interval <450 msec	0 participants	3 participants	2 participants	4 participants	2 participants	11 participants	5 participants	2 participants	8 participants
Number of Participants With Potentially Clinical Significant Categorical Changes From Baseline in Electrocardiogram (ECG) Findings in QTc Interval Max. QTcB interval 450-<480 msec	3 participants	0 participants	1 participants	3 participants	2 participants	8 participants	9 participants	1 participants	8 participants

SECONDARY outcome

Timeframe: Baseline up to end of study (maximum of 84 months)

Population: All participants who received at least 1 dose of study medication.

Parameters analyzed included: white blood cell (WBC) count plus differential, absolute (abs) neutrophil count, platelets, hemoglobin, sodium, potassium, bicarbonate, chloride, blood urea nitrogen, creatinine, glucose, uric acid, calcium, phosphate, magnesium, total protein, albumin, total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), partial prothrombin time/international normalized ratio (PTT/INR). Urinalysis: pH, specific gravity, protein, glucose, ketones, blood, leukocyte esterase, and nitrites. Pregnancy test: Serum or urine pregnancy test for women of childbearing potential. There were no changes in urine protein among the solid tumor and T-ALL/LBL participants that were clinically significant. Clinical significance was judged by the investigator.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=64 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=8 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Number of Participants With Laboratory Tests Abnormalities Meeting the Criteria of Potential Clinical Concern (Hematology and Chemistries, All Cycles) WBC	4 participants	5 participants	—	—	—	—	—	—	—
Number of Participants With Laboratory Tests Abnormalities Meeting the Criteria of Potential Clinical Concern (Hematology and Chemistries, All Cycles) ALT	22 participants	4 participants	—	—	—	—	—	—	—
Number of Participants With Laboratory Tests Abnormalities Meeting the Criteria of Potential Clinical Concern (Hematology and Chemistries, All Cycles) ALP	24 participants	3 participants	—	—	—	—	—	—	—
Number of Participants With Laboratory Tests Abnormalities Meeting the Criteria of Potential Clinical Concern (Hematology and Chemistries, All Cycles) AST	32 participants	4 participants	—	—	—	—	—	—	—
Number of Participants With Laboratory Tests Abnormalities Meeting the Criteria of Potential Clinical Concern (Hematology and Chemistries, All Cycles) Bicarbonate	15 participants	1 participants	—	—	—	—	—	—	—
Number of Participants With Laboratory Tests Abnormalities Meeting the Criteria of Potential Clinical Concern (Hematology and Chemistries, All Cycles) Bilirubin	10 participants	2 participants	—	—	—	—	—	—	—
Number of Participants With Laboratory Tests Abnormalities Meeting the Criteria of Potential Clinical Concern (Hematology and Chemistries, All Cycles) Creatinine	17 participants	1 participants	—	—	—	—	—	—	—
Number of Participants With Laboratory Tests Abnormalities Meeting the Criteria of Potential Clinical Concern (Hematology and Chemistries, All Cycles) Hypercalcaemia	17 participants	0 participants	—	—	—	—	—	—	—
Number of Participants With Laboratory Tests Abnormalities Meeting the Criteria of Potential Clinical Concern (Hematology and Chemistries, All Cycles) Hyperglycaemia	55 participants	6 participants	—	—	—	—	—	—	—
Number of Participants With Laboratory Tests Abnormalities Meeting the Criteria of Potential Clinical Concern (Hematology and Chemistries, All Cycles) Hyperkalaemia	4 participants	0 participants	—	—	—	—	—	—	—
Number of Participants With Laboratory Tests Abnormalities Meeting the Criteria of Potential Clinical Concern (Hematology and Chemistries, All Cycles) Hypermagnesaemia	1 participants	0 participants	—	—	—	—	—	—	—
Number of Participants With Laboratory Tests Abnormalities Meeting the Criteria of Potential Clinical Concern (Hematology and Chemistries, All Cycles) Hypernatraemia	4 participants	0 participants	—	—	—	—	—	—	—
Number of Participants With Laboratory Tests Abnormalities Meeting the Criteria of Potential Clinical Concern (Hematology and Chemistries, All Cycles) Hypocalcaemia	18 participants	6 participants	—	—	—	—	—	—	—
Number of Participants With Laboratory Tests Abnormalities Meeting the Criteria of Potential Clinical Concern (Hematology and Chemistries, All Cycles) Hemoglobin	45 participants	8 participants	—	—	—	—	—	—	—
Number of Participants With Laboratory Tests Abnormalities Meeting the Criteria of Potential Clinical Concern (Hematology and Chemistries, All Cycles) Lymphocytes (abs)	40 participants	8 participants	—	—	—	—	—	—	—
Number of Participants With Laboratory Tests Abnormalities Meeting the Criteria of Potential Clinical Concern (Hematology and Chemistries, All Cycles) Neutrophils (abs)	4 participants	5 participants	—	—	—	—	—	—	—
Number of Participants With Laboratory Tests Abnormalities Meeting the Criteria of Potential Clinical Concern (Hematology and Chemistries, All Cycles) Platelets	13 participants	6 participants	—	—	—	—	—	—	—
Number of Participants With Laboratory Tests Abnormalities Meeting the Criteria of Potential Clinical Concern (Hematology and Chemistries, All Cycles) Hypoalbuminaemia	43 participants	6 participants	—	—	—	—	—	—	—
Number of Participants With Laboratory Tests Abnormalities Meeting the Criteria of Potential Clinical Concern (Hematology and Chemistries, All Cycles) Hypoglycaemia	6 participants	0 participants	—	—	—	—	—	—	—
Number of Participants With Laboratory Tests Abnormalities Meeting the Criteria of Potential Clinical Concern (Hematology and Chemistries, All Cycles) Hypokalaemia	23 participants	4 participants	—	—	—	—	—	—	—
Number of Participants With Laboratory Tests Abnormalities Meeting the Criteria of Potential Clinical Concern (Hematology and Chemistries, All Cycles) Hypomagnesaemia	8 participants	1 participants	—	—	—	—	—	—	—
Number of Participants With Laboratory Tests Abnormalities Meeting the Criteria of Potential Clinical Concern (Hematology and Chemistries, All Cycles) Hyponatraemia	19 participants	3 participants	—	—	—	—	—	—	—
Number of Participants With Laboratory Tests Abnormalities Meeting the Criteria of Potential Clinical Concern (Hematology and Chemistries, All Cycles) Hypophosphataemia	54 participants	4 participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, and 10 hr post-dose)

Population: All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this outcome measure (OM).

Cmax was the maximum observed serum concentration.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=8 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=22 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=16 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants n=8 Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Maximum Observed Serum Concentration (Cmax) After a Single Dose on Cycle 1 Day 1	163 nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 62	368 nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 48	230 nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 193	691 nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 37	536 nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 72	943 nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 100	861 nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 63	1892 nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 54	1604 nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 85

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, and 10 hr post-dose)

Population: All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this OM.

Cmax(dn) was calculated by maximum observed serum concentration (Cmax) divided by administered dose.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=8 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=22 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=16 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants n=8 Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Dose-normalized Cmax [Cmax (dn)] After a Single Dose on Cycle 1 Day 1	8.1 ng/mL/mg Geometric Coefficient of Variation 63	9.2 ng/mL/mg Geometric Coefficient of Variation 48	2.9 ng/mL/mg Geometric Coefficient of Variation 193	6.9 ng/mL/mg Geometric Coefficient of Variation 37	4.1 ng/mL/mg Geometric Coefficient of Variation 72	6.3 ng/mL/mg Geometric Coefficient of Variation 100	3.9 ng/mL/mg Geometric Coefficient of Variation 63	5.7 ng/mL/mg Geometric Coefficient of Variation 54	10.7 ng/mL/mg Geometric Coefficient of Variation 85

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, and 10 hr post-dose)

Population: All treated participants who had at least 1 of the PK parameters of interest. Overall Number of Participants Analyzed (N) =number of participants evaluable for this outcome measure (OM).

AUCtau was area under the serum concentration-time profile from time 0 to tau (dosing interval). CV is the coefficient of variation.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=7 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=21 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=16 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants n=4 Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Area Under the Time-Concentration Curve From Time 0 to the Dosing Interval (AUCtau) After a Single Dose on Cycle 1 Day 1	409 nanogramhour/milliliter (nghr/mL) Geometric Coefficient of Variation 83	1329 nanogramhour/milliliter (nghr/mL) Geometric Coefficient of Variation 87	1649 nanogramhour/milliliter (nghr/mL) Geometric Coefficient of Variation 98	2204 nanogramhour/milliliter (nghr/mL) Geometric Coefficient of Variation 37	2924 nanogramhour/milliliter (nghr/mL) Geometric Coefficient of Variation 81	3677 nanogramhour/milliliter (nghr/mL) Geometric Coefficient of Variation 86	3593 nanogramhour/milliliter (nghr/mL) Geometric Coefficient of Variation 58	8014 nanogramhour/milliliter (nghr/mL) Geometric Coefficient of Variation NA Geometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric % CV was not calculated.	6412 nanogramhour/milliliter (nghr/mL) Geometric Coefficient of Variation 80

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, and 10 hr post-dose)

Population: All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this OM.

AUCtau (dn) was calculated by area under the serum concentration-time profile from time 0 to tau (dosing interval) (AUCtau) divided by administered dose. NE is not estimable.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=7 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=21 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=16 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants n=4 Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Dose-normalized AUCtau [AUCtau (dn) ] After a Single Dose on Cycle 1 Day 1	20.4 ng*hr/mL/mg Geometric Coefficient of Variation 83	33.2 ng*hr/mL/mg Geometric Coefficient of Variation 87	20.6 ng*hr/mL/mg Geometric Coefficient of Variation 98	22.0 ng*hr/mL/mg Geometric Coefficient of Variation 37	22.5 ng*hr/mL/mg Geometric Coefficient of Variation 81	24.5 ng*hr/mL/mg Geometric Coefficient of Variation 86	16.3 ng*hr/mL/mg Geometric Coefficient of Variation 58	24.3 ng*hr/mL/mg Geometric Coefficient of Variation NA Geometric %CV was NE when No. of subjects analyzed is \<3, hence data was not calculated.	42.7 ng*hr/mL/mg Geometric Coefficient of Variation 80

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, and 10 hr post-dose)

Population: All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this OM.

Tmax was the time to reach maximum serum concentration (Cmax).

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=8 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=23 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=16 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants n=8 Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Time to Reach Cmax (Tmax) After a Single Dose on Cycle 1 Day 1	1.0 hours Interval 0.9 to 1.0	1.0 hours Interval 1.0 to 1.3	2.0 hours Interval 1.0 to 8.0	1.0 hours Interval 1.0 to 2.0	2.5 hours Interval 1.0 to 4.0	1.1 hours Interval 0.5 to 4.1	2.0 hours Interval 1.0 to 4.1	1.2 hours Interval 1.0 to 2.0	1.1 hours Interval 0.9 to 4.0

SECONDARY outcome

Timeframe: Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)

Population: All participants who had at least 6 days of uninterrupted dosing prior to the Cycle 1 Day 21 PK assessment. The 6-day duration was chosen based on the observed terminal half-life of PF-03084014. N=number of participants evaluable for this OM.

Cmax was the maximum observed serum concentration. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant. CV is the coefficient of variation.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=5 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=12 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=8 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Cmax After Multiple Dose on Cycle 1 Day 21	64.5 ng/mL Geometric Coefficient of Variation NA Geometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated.	381 ng/mL Geometric Coefficient of Variation NA Geometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated.	313 ng/mL Geometric Coefficient of Variation 29	867 ng/mL Geometric Coefficient of Variation 44	421 ng/mL Geometric Coefficient of Variation 130	1246 ng/mL Geometric Coefficient of Variation 79	1864 ng/mL Geometric Coefficient of Variation 76	1828 ng/mL Geometric Coefficient of Variation 42	—

SECONDARY outcome

Timeframe: Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)

Tmax was the time to reach maximum serum concentration (Cmax). Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=5 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=12 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=8 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Time to Reach Cmax (Tmax) After Multiple Dose on Cycle 1 Day 21	1.1 hour Interval 1.0 to 1.1	1.0 hour Interval 1.0 to 1.0	1.1 hour Interval 1.0 to 4.0	1.0 hour Interval 1.0 to 2.7	3.7 hour Interval 1.0 to 8.0	1.1 hour Interval 1.0 to 4.0	1.0 hour Interval 0.5 to 2.0	1.6 hour Interval 1.0 to 2.0	—

SECONDARY outcome

Timeframe: Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)

AUCtau was area under the serum concentration-time profile from time 0 to tau (dosing interval). Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=5 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=12 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=8 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
AUCtau After Multiple Dose on Cycle 1 Day 21	309.0 ng*hr/mL Geometric Coefficient of Variation NA Geometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated.	2521 ng*hr/mL Geometric Coefficient of Variation NA Geometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated.	1572 ng*hr/mL Geometric Coefficient of Variation 42	4741 ng*hr/mL Geometric Coefficient of Variation 70	3155 ng*hr/mL Geometric Coefficient of Variation 59	6430 ng*hr/mL Geometric Coefficient of Variation 89	10520 ng*hr/mL Geometric Coefficient of Variation 89	9161 ng*hr/mL Geometric Coefficient of Variation 30	—

SECONDARY outcome

Timeframe: Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)

Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired concentration of a drug. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=5 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=12 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=8 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Apparent Volume of Distribution (Vz/F) on Cycle 1 Day 21	2810 liter (L) Geometric Coefficient of Variation NA Geometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated.	516 liter (L) Geometric Coefficient of Variation NA Geometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated.	3353 liter (L) Geometric Coefficient of Variation NA Geometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated.	986 liter (L) Geometric Coefficient of Variation 52	2048 liter (L) Geometric Coefficient of Variation 49	801 liter (L) Geometric Coefficient of Variation 144	852 liter (L) Geometric Coefficient of Variation 120	424 liter (L) Geometric Coefficient of Variation 61	—

SECONDARY outcome

Timeframe: Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)

Serum decay half-life (t1/2) is the time measured for the serum concentration to decrease by one half. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=5 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=12 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=8 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Serum Decay Half-Life (t1/2) After Multiple Dose on Cycle 1 Day 21	30.3 hours Standard Deviation NA Geometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated.	22.6 hours Standard Deviation NA Geometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated..	38.6 hours Standard Deviation NA Geometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated.	34.2 hours Standard Deviation 11.7	34.7 hours Standard Deviation 5.3	25.3 hours Standard Deviation 9.2	29.3 hours Standard Deviation 9.3	18.0 hours Standard Deviation 3.6	—

SECONDARY outcome

Timeframe: Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=5 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=12 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=8 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Apparent Oral Clearance (CL/F) on Cycle 1 Day 21	64.8 liter/hour (L/hr) Geometric Coefficient of Variation NA Geometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated.	15.9 liter/hour (L/hr) Geometric Coefficient of Variation NA Geometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated.	50.9 liter/hour (L/hr) Geometric Coefficient of Variation 42	21.1 liter/hour (L/hr) Geometric Coefficient of Variation 70	41.2 liter/hour (L/hr) Geometric Coefficient of Variation 59	23.4 liter/hour (L/hr) Geometric Coefficient of Variation 88	20.9 liter/hour (L/hr) Geometric Coefficient of Variation 89	16.4 liter/hour (L/hr) Geometric Coefficient of Variation 30	—

SECONDARY outcome

Timeframe: Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)

Cmin was the minimum serum concentration. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=5 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=12 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=8 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Minimum Observed Serum Concentration (Cmin) After Multiple Dose on Cycle 1 Day 21	10.7 ng/mL Geometric Coefficient of Variation NA Geometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated.	126 ng/mL Geometric Coefficient of Variation NA Geometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated.	59.2 ng/mL Geometric Coefficient of Variation 103	232 ng/mL Geometric Coefficient of Variation 118	206 ng/mL Geometric Coefficient of Variation 40	266 ng/mL Geometric Coefficient of Variation 102	469 ng/mL Geometric Coefficient of Variation 118	420 ng/mL Geometric Coefficient of Variation 81	—

SECONDARY outcome

Timeframe: Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)

Cavg was the average serum concentration at steady state. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=5 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=12 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=8 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Average Serum Concentration (Cavg) at Steady State on Cycle 1 Day 21	25.7 ng/mL Geometric Coefficient of Variation NA Geometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated.	210 ng/mL Geometric Coefficient of Variation NA Geometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated.	131 ng/mL Geometric Coefficient of Variation 42	395 ng/mL Geometric Coefficient of Variation 69	263 ng/mL Geometric Coefficient of Variation 59	536 ng/mL Geometric Coefficient of Variation 89	877 ng/mL Geometric Coefficient of Variation 89	763 ng/mL Geometric Coefficient of Variation 30	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, and 10 hr post-dose), Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)

Accumulation was calculated as AUCtau at steady state (Cycle 1 Day 21) divided by AUCtau after a single dose on Cycle 1 Day 1. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=5 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=12 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=8 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=1 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Accumulation Ratio (Rac) on Cycle 1 Day 21	1.18 ratio Interval 0.72 to 1.63	1.60 ratio Interval 1.45 to 1.74	1.36 ratio Interval 0.93 to 1.79	2.49 ratio Interval 1.23 to 2.86	1.98 ratio Interval 1.81 to 2.15	2.29 ratio Interval 0.95 to 4.9	2.84 ratio Interval 1.14 to 5.8	0.97 ratio Unable to calculate as only 1 participant provided value.	—

SECONDARY outcome

Timeframe: Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)

AUCtau (dn) was calculated by area under the serum concentration-time profile from time 0 to tau (dosing interval) (AUCtau) divided by administered dose. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=5 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=12 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=8 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Dose-normalized AUCtau [AUCtau (dn)] After Multiple Dose on Cycle 1 Day 21	15.4 ng*hr/mL/mg Geometric Coefficient of Variation NA Geometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated.	63.0 ng*hr/mL/mg Geometric Coefficient of Variation NA Geometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated.	19.7 ng*hr/mL/mg Geometric Coefficient of Variation 41	47.4 ng*hr/mL/mg Geometric Coefficient of Variation 70	24.3 ng*hr/mL/mg Geometric Coefficient of Variation 59	42.9 ng*hr/mL/mg Geometric Coefficient of Variation 88	47.9 ng*hr/mL/mg Geometric Coefficient of Variation 89	61.1 ng*hr/mL/mg Geometric Coefficient of Variation 30	—

SECONDARY outcome

Timeframe: Cycle 1 Day 21 (pre-dose and 0.5, 1, 2, 4, 10, 24, 48, 96 and 120 hr post-dose)

Cmax(dn) was calculated by maximum observed serum concentration (Cmax) divided by administered dose. Cycle 1 Day 21 PK parameter summaries are presented only for participants who were considered to be dose compliant.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=5 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=12 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=8 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Dose-normalized Cmax [Cmax (dn)] After Multiple Dose on Cycle 1 Day 21	3.2 ng/mL/mg Geometric Coefficient of Variation NA Geometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated.	9.6 ng/mL/mg Geometric Coefficient of Variation NA Geometric %CV was not estimable when number of participants analyzed is less than 3, hence data for Geometric %CV was not calculated.	3.9 ng/mL/mg Geometric Coefficient of Variation 29	8.7 ng/mL/mg Geometric Coefficient of Variation 44	3.2 ng/mL/mg Geometric Coefficient of Variation 130	8.3 ng/mL/mg Geometric Coefficient of Variation 79	8.5 ng/mL/mg Geometric Coefficient of Variation 76	12.2 ng/mL/mg Geometric Coefficient of Variation 42	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose) or Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)

Population: Solid tumor participants who were enrolled in the food-effect sub-study, were treated and had evaluable PK data under both fed and fasted states.

AUCtau was area under the serum concentration-time profile from time 0 to tau (dosing interval).

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=7 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
AUCtau in the Fasted State for Solid Tumor Participants	2547 ng*hr/mL Geometric Coefficient of Variation 101	9353 ng*hr/mL Geometric Coefficient of Variation 100	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose) or Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)

Population: Solid tumor participants who were enrolled in the food-effect sub-study, were treated and had evaluable PK data under both fed and fasted states.

AUCtau was area under the serum concentration-time profile from time 0 to tau (dosing interval).

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=7 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
AUCtau in the Fed State for Solid Tumor Participants	3163 ng*hr/mL Geometric Coefficient of Variation 83	5573 ng*hr/mL Geometric Coefficient of Variation 39	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose) or Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)

Population: Solid tumor participants who were enrolled in the food-effect sub-study, were treated and had evaluable PK data under both fed and fasted states.

Cmax was the maximum observed serum concentration.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=9 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Cmax in the Fasted State for Solid Tumor Participants	795.1 ng/mL Geometric Coefficient of Variation 104	2334 ng/mL Geometric Coefficient of Variation 93	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose) or Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)

Population: Solid tumor participants who were enrolled in the food-effect sub-study, were treated and had evaluable PK data under both fed and fasted states.

Cmax was the maximum observed serum concentration.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=9 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Cmax in the Fed State for Solid Tumor Participants	862.3 ng/mL Geometric Coefficient of Variation 74	924.4 ng/mL Geometric Coefficient of Variation 40	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose) or Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)

Population: Solid tumor participants who were enrolled in the food-effect sub-study, were treated and had evaluable PK data under both fed and fasted states. Due to the limited number of evaluable participants (7 at 150 mg BID and 4 at 220 mg BID for Cmax) and a generally dose-proportional exposure (AUCtau and Cmax), data were combined for the 2 dose levels.

AUCtau(dn) was calculated by area under the serum concentration-time profile from time 0 to tau (dosing interval) (AUCtau) divided by administered dose.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=11 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Dose-normalized AUCtau [AUCtau(dn)] in the Fasted State for Solid Tumor Participants	23.71 ng*hr/mL/mg Geometric Coefficient of Variation 115	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose) or Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)

Population: Solid tumor participants who were enrolled in the food-effect sub-study, started treatment and had evaluable PK data under both fed and fasted states. Due to the limited number of evaluable participants (7 at 150 mg BID and 4 at 220 mg BID for Cmax) and a generally dose-proportional exposure (AUCtau and Cmax), data were combined for 2 dose levels.

AUCtau(dn) was calculated by area under the serum concentration-time profile from time 0 to tau (dosing interval) (AUCtau) divided by administered dose.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=11 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Dose-normalized AUCtau [AUCtau(dn)] in the Fed State for Solid Tumor Participants	22.54 ng*hr/mL/mg Geometric Coefficient of Variation 67	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose) or Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)

Population: Participants who were enrolled in the food-effect sub-study, started treatment and had evaluable PK data under both fed and fasted states. Due to the limited number of evaluable participants (9 at 150 mg BID and 4 at 220 mg BID for Cmax) and a generally dose-proportional exposure (AUCtau and Cmax), data were combined for the 2 dose levels.

Cmax(dn) was calculated by maximum observed serum concentration (Cmax) divided by administered dose.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=13 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Dose-normalized Cmax [Cmax(dn)] in the Fasted State for Solid Tumor Participants	6.56 ng/mL/mg Geometric Coefficient of Variation 106	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose) or Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose).

Population: Solid tumor participants who were enrolled in the food-effect sub-study, were treated and had evaluable PK data under both fed and fasted states. Due to the limited number of evaluable participants (9 at 150 mg BID and 4 at 220 mg BID for Cmax) and a generally dose-proportional exposure (AUCtau and Cmax), data were combined for the 2 dose levels.

Cmax(dn) was calculated by maximum observed serum concentration (Cmax) divided by administered dose.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=13 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Dose-Normalized Cmax [Cmax(dn)] in the Fed State for Solid Tumor Participants	5.22 ng/mL/mg Geometric Coefficient of Variation 64	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)

Population: All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this OM.

AUCtau was area under the serum concentration-time profile from time 0 to tau (dosing interval). Data for this outcome measure was planned to be analyzed for two arms only.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=8 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
AUCtau on Cycle 2 Day 1	2784 ng*hr/mL Geometric Coefficient of Variation 80	11870 ng*hr/mL Geometric Coefficient of Variation 57	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)

Population: All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this OM.

AUCtau(dn) was calculated by area under the serum concentration-time profile from time 0 to tau (dosing interval) (AUCtau) divided by administered dose. Data for this outcome measure was planned to be analyzed for two arms only.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=8 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Dose-normalized AUCtau [AUCtau (dn)] on Cycle 2 Day 1	18.6 ng*hr/mL/mg Geometric Coefficient of Variation 80	54.0 ng*hr/mL/mg Geometric Coefficient of Variation 57	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)

Population: All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this OM.

Cmax was the maximum observed serum concentration. Data for this outcome measure was planned to be analyzed for two arms only.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=9 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Cmax on Cycle 2 Day 1	834.6 ng/mL Geometric Coefficient of Variation 76	2640 ng/mL Geometric Coefficient of Variation 63	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)

Population: All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this OM.

Cmax(dn) was calculated by maximum observed serum concentration (Cmax) divided by administered dose. Data for this outcome measure was planned to be analyzed for two arms only.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=9 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Dose-normalized Cmax [Cmax (dn)] on Cycle 2 Day 1	5.6 ng/mL/mg Geometric Coefficient of Variation 76	12.0 ng/mL/mg Geometric Coefficient of Variation 63	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 2 Day 1 (pre-dose and 0.5, 1, 2, 4, 10 and 24 hr post-dose)

Population: All treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for this OM.

Tmax was the time to reach maximum serum concentration (Cmax). Data for this outcome measure was planned to be analyzed for two arms only.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=9 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Tmax on Cycle 2 Day 1	2.00 hr Interval 1.0 to 4.03	1.53 hr Interval 0.98 to 4.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Cycle 2 Day 1, Cycle 3 Day 1 and then Day 1 (plus [+] or minus [-] 5 days) of every odd cycle or as clinically indicated, up to Cycle 9; afterwards assessed on Day 1 (+ or -5 days) every 4 cycles

Population: All solid tumor participants who received study treatment, had baseline assessments and at least 1 on study tumor assessment prior to any new anti-cancer therapies were considered evaluable for response.

Objective response (OR) was defined as confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as \>=30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study \>=4 weeks after initial documentation of response.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=5 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=18 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=10 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=1 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Percentage of Solid Tumor Participants With Objective Response (OR)	33.3 percentage of participants Interval 0.8 to 90.6	0 percentage of participants Interval 0.0 to 70.8	66.7 percentage of participants Interval 9.4 to 99.2	0 percentage of participants Interval 0.0 to 52.2	0 percentage of participants Interval 0.0 to 70.8	5.6 percentage of participants Interval 0.1 to 27.3	10.0 percentage of participants Interval 0.3 to 44.5	100 percentage of participants Interval 2.5 to 100.0	—

SECONDARY outcome

Timeframe: Baseline until first documented objective progression (up to maximum of 84 months)

Population: All solid tumor participants who received at least 1 dose of study medication.

Time from Cycle 1 Day 1 to first documentation of disease progression. Progression was defined as per RECIST version 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or target lesions over nadir, uneuivocal progression of non-target disease, or the appearance of new lesions. TTP (months) was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=8 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=23 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=16 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Time to Tumor Progression (TTP) for Solid Tumor Participants	NA months Interval 0.8 to Data was not estimable due to insufficient number of participants with events.	1.2 months Interval 1.0 to 2.8	NA months Interval 1.7 to Data was not estimable due to insufficient number of participants with events.	3.1 months Interval 1.0 to Data was not estimable due to insufficient number of participants with events.	4.3 months Interval 1.6 to 19.5	1.6 months Interval 1.4 to 6.0	1.5 months Interval 1.1 to 4.2	NA months Data was not estimable due to insufficient number of participants with events.	—

SECONDARY outcome

Timeframe: Baseline, Cycle 2 Day 1, Cycle 3 Day 1 and then Day 1 (+ or -5 days) of every odd cycle or as clinically indicated, up to Cycle 9. Afterwards, assessed on Day 1 (+ or -5 days) every 4 cycles (up to maximum of 84 months)

Population: Only solid tumor participants with an OR were analyzed; however, all these participants were censored as of the time of data cut-off on 09 January 2013. Of these 6 participants, 4 participants were still on study with 1 participant discontinued for non-compliance and the other 1 participant missing tumor assessment.

Time from the first documentation of OR to objective disease progression or death due to any cause. DR was only calculated for participants with an OR. DR (months) was calculated as (date of first documentation of objective progression or death minus date of first documentation of PR or CR plus 1) divided by 30.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=1 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=1 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=1 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=1 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Duration of Response (DR) for Solid Tumor Participants	NA months Data was not estimable due to insufficient number of participants with events.	NA months Data was not estimable due to insufficient number of participants with events.	NA months Data was not estimable due to insufficient number of participants with events.	NA months Data was not estimable due to insufficient number of participants with events.	NA months Data was not estimable due to insufficient number of participants with events.	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Cycle 2 Day 1, Cycle 3 Day 1 and then Day 1 (+ or - 5 days) of every odd cycle or as clinically indicated, up to Cycle 9; afterwards assessed on Day 1 (+ or -5 days) every 4 cycles (up to maximum of 84 months)

Population: All solid tumor participants who received at least 1 dose of study medication.

PFS was defined as the time from Cycle 1 Day 1 to date of first documentation of progression or death due to any cause. Progression was defined as per RECIST version 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or target lesions over nadir, unequivocal progression of non-target disease, or the appearance of new lesions. PFS (months) was calculated as (the first event date minus the date of first dose of study medication plus 1) divided by 30.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=8 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=4 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=23 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=16 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Progression-Free Survival (PFS) for Solid Tumor Participants	NA months Interval 0.8 to Unable to calculate as 2 participants were censored and only 1 participant was evaluable.	1.2 months Interval 1.0 to 2.8	NA months Interval 1.7 to Unable to calculate as 3 participants were censored and only 1 participant was evaluable.	2.3 months Interval 0.4 to The upper 95% confidence limit can not be determined due to limited number of participants with PFS.	4.3 months Interval 1.6 to 19.5	1.6 months Interval 1.4 to 6.0	1.5 months Interval 1.1 to 4.2	NA months Unable to calculate as all 3 participants were censored.	—

SECONDARY outcome

Timeframe: Baseline, Cycle 2 Day 1, Cycle 3 Day 1 and then Day 1 (+ or - 5 days) of every odd cycle or as clinically indicated, up to Cycle 9 (up to maximum of 84 months)

Population: All T-ALL/LBL participants who received at least 1 dose of study medication.

OR was adapted from International Working Group Response Criteria for Acute Myeloid Leukemia (AML). The response categories of interest were CR, complete response with incomplete hematopoietic recovery (CRi), and PR. CR: ANC \>1500/microliter (uL), no circulating blasts. Platelets \>100,000/uL, \<5% marrow blast cells, no extramedullary disease, bone marrow cellularity \>20% with tri-lineage hematopoiesis and \<5% marrow blast cells, none of which were neoplastic; CRi: same as CR but ANC may be \>1500/uL or platelet count \>100,000/uL, no requirement on bone marrow cellularity; PR: same as CR but bone marrow with \>= 50% reduction of leukemia blast cells and an absolute blast count between 5% and 25%.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=8 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Percentage of T-ALL/LBL Participants With OR	12.5 percentage of participants Interval 0.3 to 52.7	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Cycle 2 Day 1, Cycle 3 Day 1 and then Day 1 (+ or - 5 days) of every odd cycle or as clinically indicated, up to Cycle 9 (up to maximum of 84 months)

Population: Due to halting of T-AA/LBL participants enrollment and limited number of evaluable participants, data for RFS was not collected.

The RFS of CR was defined as the time from the date of first attaining CR to the date of relapse or death from any cause, whichever occurred first. Similarly, the RFS of CR + CRi (or RFS of CR + CRi + PR) was defined as the time from the date of first attaining CR + CRi (or CR + CRi + PR) to the date of relapse or death from any cause, whichever occurred first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Cycle 2 Day 1, Cycle 3 Day 1 and then Day 1 (+ or - 5 days) of every odd cycle or as clinically indicated, up to Cycle 9 (up to maximum of 84 months)

Population: Due to halting of T-AA/LBL participants enrollment and limited number of evaluable participants, data for PBR was not collected.

PBR was the maximum percentage of peripheral blast count reduction for each participant who received at least one dose of study medication. PBR was derived by the Sponsor from percentage of peripheral blood Blast Count reported by sites.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 21 (-5 days)

Population: Pharmacodynamic Biomarker analysis set was defined separately for T-ALL and advanced solid tumor malignancy participants. In both cases it will comprise all participants enrolled in study having at least one biomarker assessment at baseline and at least one assessment after being treated. Here, "N" signifies participants evaluable for this OM.

Gene expression analysis in tumor biopsies was done using cDNA prepared from RNA extracted from tumor biopsies. Gene expression was measured by custom Taqman low density array (TLDA) cards run on Applied Biosystems 7900HT Fast Real-Time polymerase chain reaction (PCR) system. Changes from baseline were calculated as ratios to baseline. Only Hes4 gene showed consistent down modulation across dosing cohorts (150 mg and 220 mg BID) and therefore results were reported for Hes4 only. Data for this outcome measure was planned to be analyzed for two arms only.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=3 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Changes in Expression Levels of Notch 1 Target Genes in Tumor Biopsies for Solid Tumor Participants: Hairy and Enhancer of Split-4 (Hes4) Gene Expression Levels on Cycle 1 Day 21 Relative to That at Baseline	0.9 ratio Standard Deviation 0.57	0.5 ratio Standard Deviation 0.50	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (morning), Cycle 1 Days 8, 15 and 21 (morning, matched with the first PK sample of the particular day), Cycle 1 Day 21 (24, 48, and 120 hr post-dose) and at end of treatment (EOT)

Population: Pharmacodynamic biomarker analysis set. In both cases, it will comprise all participants enrolled in study having at least 1 biomarker assessment at baseline and at least 1 assessment after being treated. Here, "N"=participants evaluable for this OM. This OM was planned to be analyze for T-ALL/LBL arm only.

Ribonucleic acid (RNA) was extracted from peripheral blood and used as a template to synthesize complementary deoxyribonucleic acid (cDNA). Gene expression in cDNA was measured by custom Taqman low density array (TLDA) cards run on Applied Biosystems 7900HT Fast Real-Time polymerase chain reaction (PCR) system. Changes from baseline were calculated as ratios to baseline. Results were reported Only for Hes4 as this was the only gene to show consistent down modulation across dosing cohorts (150 mg and 220 mg).

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=8 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Changes From Baseline in Expression Levels of Notch 1 Target Genes in Peripheral Blood for T-ALL/LBL Participants: Hes4 Gene Expression Levels on Cycle 1 Day 8, Cycle 1 Day 15, Cycle 1 Day 21 Relative to That at Baseline Cycle 1 Day 8	0.7 ratio Standard Deviation 0.65	—	—	—	—	—	—	—	—
Changes From Baseline in Expression Levels of Notch 1 Target Genes in Peripheral Blood for T-ALL/LBL Participants: Hes4 Gene Expression Levels on Cycle 1 Day 8, Cycle 1 Day 15, Cycle 1 Day 21 Relative to That at Baseline Cycle 1 Day 15	0.3 ratio Standard Deviation 0.41	—	—	—	—	—	—	—	—
Changes From Baseline in Expression Levels of Notch 1 Target Genes in Peripheral Blood for T-ALL/LBL Participants: Hes4 Gene Expression Levels on Cycle 1 Day 8, Cycle 1 Day 15, Cycle 1 Day 21 Relative to That at Baseline Cycle 1 Day 21	0.4 ratio Standard Deviation 0.27	—	—	—	—	—	—	—	—
Changes From Baseline in Expression Levels of Notch 1 Target Genes in Peripheral Blood for T-ALL/LBL Participants: Hes4 Gene Expression Levels on Cycle 1 Day 8, Cycle 1 Day 15, Cycle 1 Day 21 Relative to That at Baseline EOT	2.0 ratio Standard Deviation NA Data for standard deviation was not estimable since only 1 participant was analyzed.	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (morning), Cycle 1 Days 8 and 21 (pre-dose)

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=11 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=7 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Changes in Expression Levels of Notch 1 Target Genes in Peripheral Blood for Solid Tumor Participants: Hes4 Gene Expression Level on Cycle 1 Day 8 and Cycle 1 Day 21 Relative to That at Baseline Cycle 1 Day 8	0.3 ratio Standard Deviation 0.24	0.1 ratio Standard Deviation 0.14	—	—	—	—	—	—	—
Changes in Expression Levels of Notch 1 Target Genes in Peripheral Blood for Solid Tumor Participants: Hes4 Gene Expression Level on Cycle 1 Day 8 and Cycle 1 Day 21 Relative to That at Baseline Cycle 1 Day 21	0.3 ratio Standard Deviation 0.33	0.0 ratio Standard Deviation 0.02	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Days 8 and 15 (pre-dose AM), Cycle 1 Day 21 (pre-dose AM and 24, 48 and 120 hr post-dose) and end of treatment (EOT).

Population: No data were reported for the results of NICD measurement in T-ALL/LBL participants because NICD levels fell below the limit of quantitation of the assay in most cases.

Notch intracellular domain (NICD) levels was measured in peripheral blood mononuclear cell (PBMC) pellets using a validated enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 1 and Cycle 2 Day 1

Population: NICD analyses in bone marrow samples were not done because the number of bone marrow samples received was insufficient and because the analyses were not mandatory per protocol.

Notch intracellular domain (NICD) was to be measured in bone marrow monoculear cell (BMMC) cell pellets using a validated ELISA.

Outcome measures

Outcome data not reported

POST_HOC outcome

Population: Only solid tumor participants with an OR were analyzed.

Time to response (TTR) was only defined for participants with an objective response (OR). TTR (months) was calculated as (date of first documentation of PR or CR minus date of first dose of study medication plus 1) divided by 30.

Outcome measures

Outcome measures
Measure	PF-03084014 150 mg BID in Solid Tumor Participants n=1 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=2 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants n=1 Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=1 Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants n=1 Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in Solid Tumor Participants PF-03084014 150 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants PF-03084014 220 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 330 mg BID in Solid Tumor Participants PF-03084014 330 mg was administered orally BID to participants with solid tumors as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 150 mg BID in T-ALL/LBL Participants PF-03084014 150 mg was administered orally BID to participants with T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.
Time to Response (TTR) for Solid Tumor Participants	11.2 months Data for upper and lower limit of 95% CI were not estimable since only 1 participant was analyzed.	19.4 months Interval 8.5 to 30.4	2.9 months Data for upper and lower limit of 95% CI were not estimable since only 1 participant was analyzed.	10.1 months Data for upper and lower limit of 95% CI were not estimable since only 1 participant was analyzed.	5.9 months Data for upper and lower limit of 95% CI were not estimable since only 1 participant was analyzed.	—	—	—	—

Adverse Events

PF-03084014 20 mg BID in Solid Tumor Participants

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

PF-03084014 40 mg BID in Solid Tumor Participants

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

PF-03084014 80 mg BID in Solid Tumor Participants

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

PF-03084014 100 mg BID in Solid Tumor Participants

Serious events: 4 serious events

Other events: 7 other events

Deaths: 0 deaths

PF-03084014 130 mg BID in Solid Tumor Participants

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

PF-03084014 150 mg BID in Solid Tumor Participants

Serious events: 8 serious events

Other events: 23 other events

Deaths: 0 deaths

PF-03084014 150 mg BID in T-ALL/LBL Participants

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

PF-03084014 220 mg BID in Solid Tumor Participants

Serious events: 7 serious events

Other events: 16 other events

Deaths: 0 deaths

PF-03084014 330 mg BID in Solid Tumor Participants

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PF-03084014 20 mg BID in Solid Tumor Participants n=3 participants at risk PF-03084014 20 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 40 mg BID in Solid Tumor Participants n=3 participants at risk PF-03084014 40 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 80 mg BID in Solid Tumor Participants n=4 participants at risk PF-03084014 80 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 100 mg BID in Solid Tumor Participants n=8 participants at risk PF-03084014 100 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 130 mg BID in Solid Tumor Participants n=4 participants at risk PF-03084014 130 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 150 mg BID in Solid Tumor Participants n=23 participants at risk PF-03084014 150 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 150 mg BID in T-ALL/LBL Participants n=8 participants at risk PF-03084014 150 mg was administered orally BID to participants with T-ALL/LBL as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=16 participants at risk PF-03084014 220 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 participants at risk PF-03084014 330 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations GRAM POSITIVE COCCI	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/23 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	50.0% 1/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Gastrointestinal disorders Constipation	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Gastrointestinal disorders Nausea	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	50.0% 2/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
General disorders Disease progression	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 2/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
General disorders General physical health deterioration	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
General disorders Malaise	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
General disorders Pyrexia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Immune system disorders Anaphylactic shock	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Immune system disorders Drug hypersensitivity	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Infections and infestations Abdominal abscess	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Infections and infestations Fungal infection	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Infections and infestations Pneumonia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Infections and infestations Sepsis	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	50.0% 1/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Arterial injury	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Injury	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations Blood bilirubin increased	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations Hepatic enzyme abnormal	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations Neutrophil count increased	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations White blood cell count increased	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	50.0% 1/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Product Issues Device dislocation	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Psychiatric disorders Confusional state	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Psychiatric disorders Mental status changes	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/2 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.

Other adverse events

Other adverse events
Measure	PF-03084014 20 mg BID in Solid Tumor Participants n=3 participants at risk PF-03084014 20 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 40 mg BID in Solid Tumor Participants n=3 participants at risk PF-03084014 40 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 80 mg BID in Solid Tumor Participants n=4 participants at risk PF-03084014 80 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 100 mg BID in Solid Tumor Participants n=8 participants at risk PF-03084014 100 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 130 mg BID in Solid Tumor Participants n=4 participants at risk PF-03084014 130 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 150 mg BID in Solid Tumor Participants n=23 participants at risk PF-03084014 150 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 150 mg BID in T-ALL/LBL Participants n=8 participants at risk PF-03084014 150 mg was administered orally BID to participants with T-ALL/LBL as single agent for 21 days per cycle continuously (except for Cycle 1). On Cycle 1 Day 21, only the morning dose was administered, followed by a 7-day washout interval.	PF-03084014 220 mg BID in Solid Tumor Participants n=16 participants at risk PF-03084014 220 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.	PF-03084014 330 mg BID in Solid Tumor Participants n=3 participants at risk PF-03084014 330 mg was administered orally BID, beginning on Day 1 of each cycle, for 21 days. In Cycle 1 only, participants with advanced solid tumor malignancies received PF-03084014 BID for 21 days (on Cycle 1 Day 21 only the morning dose was administered) followed by 7 days' off-treatment for the purpose of PK assessments. In Cycle 2 and beyond, PF-03084014 was administered BID continuously.
Psychiatric disorders Confusional state	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Psychiatric disorders Depressed mood	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Psychiatric disorders Depression	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Psychiatric disorders Enuresis	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	50.0% 2/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	62.5% 5/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	31.2% 5/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Psychiatric disorders Hallucination	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Psychiatric disorders Insomnia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	37.5% 3/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	18.8% 3/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Psychiatric disorders Obsessive-compulsive disorder	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Renal and urinary disorders Dysuria	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Renal and urinary disorders Renal pain	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Reproductive system and breast disorders Amenorrhoea	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Reproductive system and breast disorders Breast disorder	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Reproductive system and breast disorders Scrotal mass	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Reproductive system and breast disorders Sexual dysfunction	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	50.0% 4/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 2/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Epistaxis	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 2/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	50.0% 4/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Rhonchi	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Sinus congestion	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Blister	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Cold sweat	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Exfoliative rash	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Nail bed disorder	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Rash	66.7% 2/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	50.0% 4/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	18.8% 3/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	66.7% 2/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
General disorders Influenza like illness	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders PRURITIS	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/23 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Blood and lymphatic system disorders Leukopenia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Blood and lymphatic system disorders Splenomegaly	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Blood and lymphatic system disorders Thrombocytopenia	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Cardiac disorders Palpitations	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Cardiac disorders Tachycardia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Ear and labyrinth disorders Hypoacusis	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Ear and labyrinth disorders Vertigo	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Eye disorders Dry eye	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Eye disorders Eye irritation	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Eye disorders Eye movement disorder	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Eye disorders Eye pain	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Eye disorders Eye pruritus	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Eye disorders Orbital oedema	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Eye disorders Photophobia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Eye disorders Visual impairment	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Eye disorders Vitreous floaters	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal discomfort	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 2/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	37.5% 3/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Gastrointestinal disorders Ascites	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
General disorders Mucosal dryness	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Gastrointestinal disorders Constipation	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 2/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	50.0% 2/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	75.0% 3/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	75.0% 12/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	100.0% 3/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	31.2% 5/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Gastrointestinal disorders Faeces soft	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Gastrointestinal disorders Flatulence	66.7% 2/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Gastrointestinal disorders Nausea	66.7% 2/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	75.0% 3/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	62.5% 5/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	62.5% 5/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	50.0% 8/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	66.7% 2/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Gastrointestinal disorders Oesophageal ulcer haemorrhage	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Gastrointestinal disorders Oral pain	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Gastrointestinal disorders Toothache	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	50.0% 2/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	62.5% 5/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	62.5% 5/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	31.2% 5/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	66.7% 2/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
General disorders Asthenia	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
General disorders Chest discomfort	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
General disorders Chest pain	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
General disorders Chills	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
General disorders Early satiety	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
General disorders Facial pain	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
General disorders Fatigue	66.7% 2/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	66.7% 2/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	50.0% 2/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	43.8% 7/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	43.8% 7/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
General disorders General physical health deterioration	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
General disorders Induration	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
General disorders Mucosal inflammation	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	66.7% 2/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
General disorders Oedema peripheral	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
General disorders Pain	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
General disorders Pyrexia	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	37.5% 3/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 2/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Hepatobiliary disorders Hyperbilirubinaemia	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Hepatobiliary disorders Ocular icterus	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Immune system disorders Contrast media allergy	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Immune system disorders Seasonal allergy	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Infections and infestations Candida infection	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Infections and infestations Conjunctivitis	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Infections and infestations Ear infection	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Infections and infestations Eye infection	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Infections and infestations Folliculitis	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Infections and infestations Gastroenteritis	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Infections and infestations Gastroenteritis viral	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Infections and infestations Influenza	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Infections and infestations Laryngitis	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Infections and infestations Lung infection	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Infections and infestations Oral herpes	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Infections and infestations Oropharyngeal candidiasis	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Infections and infestations Pneumonia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Infections and infestations Rhinitis	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Infections and infestations Sinusitis	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	50.0% 2/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Infections and infestations Tooth infection	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	37.5% 3/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Infections and infestations Urinary tract infection	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Infections and infestations Urinary tract infection viral	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Infections and infestations Viral infection	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Stoma site pain	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Wound complication	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations Alanine aminotransferase increased	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	50.0% 2/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations Alpha 1 foetoprotein increased	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations Aspartate aminotransferase increased	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	50.0% 2/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 2/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations Bacterial test positive	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations Blood alkaline phosphatase increased	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations Blood bilirubin increased	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations Blood creatine phosphokinase increased	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations Blood creatinine increased	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations Blood lactate dehydrogenase increased	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations Blood urea increased	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations C-reactive protein increased	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations Electrocardiogram QT prolonged	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	50.0% 2/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations Fungal test positive	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations Gamma-glutamyltransferase	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations Haemoglobin decreased	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations International normalised ratio increased	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations Platelet count decreased	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations Prothrombin time prolonged	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations Transaminases increased	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations Weight decreased	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Investigations White blood cell count increased	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Cachexia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Decreased appetite	66.7% 2/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	66.7% 2/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	87.5% 7/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	18.8% 3/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Dehydration	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	37.5% 3/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Fluid overload	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Fluid retention	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypokalaemia	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	62.5% 5/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 2/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	50.0% 2/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	50.0% 2/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	75.0% 6/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	56.2% 9/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Malnutrition	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	50.0% 2/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 2/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Bone cyst	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Bone swelling	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Bursitis	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Joint hyperextension	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Joint stiffness	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Osteopenia	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Central nervous system leukaemia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Nervous system disorders Balance disorder	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Nervous system disorders Cerebrovascular disorder	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Nervous system disorders Disturbance in attention	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Nervous system disorders Dizziness	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Nervous system disorders Dysgeusia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Nervous system disorders Dyskinesia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Nervous system disorders Headache	66.7% 2/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	18.8% 3/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Nervous system disorders Hypoaesthesia	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Nervous system disorders Intracranial aneurysm	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Nervous system disorders Memory impairment	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Nervous system disorders Neuralgia	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Nervous system disorders Neuropathy peripheral	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 2/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Nervous system disorders Paraparesis	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Nervous system disorders Presyncope	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Nervous system disorders Sinus headache	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Nervous system disorders Speech disorder	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Nervous system disorders Syncope	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Psychiatric disorders Affective disorder	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Psychiatric disorders Anxiety	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Vascular disorders Deep vein thrombosis	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Vascular disorders Flushing	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Vascular disorders Hot flush	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	25.0% 1/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	12.5% 1/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Vascular disorders Lymphoedema	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Vascular disorders Peripheral vascular disorder	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	33.3% 1/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.
Vascular disorders Vena cava thrombosis	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/4 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/8 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	6.2% 1/16 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.	0.00% 0/3 • Baseline up to end of study (maximum of 84 months) Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in another participant or 1 participant may have experienced both serious and non-serious event. The safety analysis set includes all enrolled participants who received at least 1 dose of study medication.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER